Date Initiated by Firm |
July 16, 2014 |
Date Posted |
July 29, 2014 |
Recall Status1 |
Terminated 3 on December 31, 2014 |
Recall Number |
Z-2128-2014 |
Recall Event ID |
68794 |
510(K)Number |
K042614
|
Product Classification |
Agent tooth bonding, resin - Product Code KLE
|
Product |
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. |
Code Information |
Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015. |
Recalling Firm/ Manufacturer |
Novocol, Inc. 416 S Taylor Ave Louisville CO 80027-3028
|
For Additional Information Contact |
Arsalan Rizvi 303-665-7535 Ext. 214
|
Manufacturer Reason for Recall |
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
|
FDA Determined Cause 2 |
Process design |
Action |
An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock. |
Quantity in Commerce |
60 |
Distribution |
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = KLE and Original Applicant = S & C POLYMER GMBH
|